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Amid Purity Questions, Drug Company Recalls Products

A drug producer linked to the pharmacy at the center of a national meningitis outbreak announced a recall of all of its products Wednesday after federal regulators found that it had not provided enough assurance that all the medicines it made were sterile.

The company, Ameridose, which is based in Massachusetts and is a major supplier of sterile injectable medications to hospitals across the country, underscored that there had been no reports of impurities in any of its products and said that it had announced the recall “out of an abundance of caution.”

The company sells more than 2,200 blended drug products, including tranquilizers, anesthetics and antibiotics, according to its Web site. The drugs are pumped into both injectable and oral syringes, as well as intravenous medicine bags. It said it would post the precise list of all the products on its Web site, ameridose.com.

The announcement represented another blow to the family behind Ameridose and its sister company, the New England Compounding Center, whose fungal-tainted steroid medication was responsible for the deaths of 29 people. Ameridose has taken pains to emphasize that it is legally distinct from New England Compounding. But the companies are owned by some of the same people. Federal officials have said Ameridose is part of the investigation because of concerns that it had some of the same business practices as New England Compounding.

Federal and state regulators have suspended operations at Ameridose until Monday. The Massachusetts Department of Public Health said Wednesday that the agreement with the company was “under review.”

Dr. Janet Woodcock, the director of the Center for Drug Evaluation and Research at the Food and Drug Administration, said in a telephone interview that the company offered to recall all of its products after federal officials shared the results of their inspection, which found fault with some of its sterility “assurances.”

Ameridose said in a statement that the F.D.A. had notified the company that the agency would “be seeking improvements in Ameridose’s sterility testing process.”

Dr. Woodcock emphasized that the recall was different from that of New England Compounding, where there was known contamination. The agency is not asking health care providers to track down patients who were given Ameridose products, she said, because there have been no reports of problems. Instead, providers are being asked to send the products back to the company.

In a statement, Ameridose said it had shipped more than 70 million “units of product” since its founding in 2006 without problems.

It said it had agreed to recall its products “because customer confidence is paramount to its business.”

Hospitals have reported difficulties in obtaining certain types of injectable medications that Ameridose produces since the company first suspended its operations, and Wednesday’s recall was likely to exacerbate those shortages.

Dr. Woodcock said that the agency was working to mitigate the shortages, in part by asking other manufacturers to increase production. But she added that concerns about lack of sterility were also important.

“We have to balance the risk of lack of sterility assurance against the issues of products not being available,” she said. “That’s a line we walk every day.”

A version of this article appears in print on November 1, 2012, on page A20 of the New York edition with the headline: Amid Purity Questions, Drug Company Recalls Products. Order Reprints|Today's Paper|Subscribe